Pharma tycoons climb as stocks zoom

 

Over a dozen people from pharmaceuticals and healthcare industry made it to the Forbes list of India's 100 Richest People.

Apart from the second richest Indian Dilip Shanghvi of Sun Pharmaceutical Industries (net worth $18 billion), the list includes vaccine king Cyrus Poonawala (net worth $7.9 billion) who owns Serum Institute of India, who made it to the top ten, Desh Bandhu Gupta (net worth of $5.9 billion) of Lupin, Pankaj Patel ($4.1 billion) of Cadila Healthcare, Yusuf Hamied ($3 billion) of Cipla, PV Ramprasad Reddy ($2.8 billion) of Aurobindo Pharma, Reddy Family ($2.6 billion) of Dr Reddy's Laboratories, Samprada Singh ($2 billion of Alkem Laboratories) and Glenn Saldanha ($2 billion) of Glenmark.

 

Forbes in its list said Dilip Shanghvi's wealth flatlined as Sun Pharma reported a 46% drop in net profit due to merger costs linked to acquisition of rival Ranbaxy Industries.

The list of 100 people also saw Leena Tiwari of USV Pharma, Mannalal Agarwal of Ajanta Pharma and Chirayu Amin of Alembic Pharmaceuticals making an entry with net worths of $1.9 billion, $1.4 billion and $1.2 billion, respectively.

Both Mannalal Agrawal and Chirayu Amin debut on list after shares of Ajanta Pharma more than doubled in the past year, while that of Alembic Pharmaceuticals rose 66% in the past 12 months on the back of higher revenues and profits.

The list includes Rajendra Agarwal of Macleod's Pharmaceuticals, Habil Khorakiwala of Wockhardt, Ajay Piramal of Piramal Enterprises, Malvinder and Shivinder Singh of Fortis, all with net worths of $1.8 billion. It also lists B R Shetty ($1.7 billion) of UAE-based NMC Healthcare, Dilip and Anand Surana ($1.6 billion) of Micro Labs, Ramesh Juneja ($1.5 billion) of Mankind Pharma and Azad Moopen ($1.5 billion) of Aster DM Healthcare.

Sun Pharma arm suffers US jolt

 

In a setback to Sun Pharma Advanced Research Company (SPARC), the US Food and Drug Administration (USFDA) has revoked an approval for its anti-epileptic drug because of manufacturing quality concerns at the Halol plant of Sun Pharmaceutical Industries.

SPARC is the research & development arm of Sun Pharma and it has plans to manufacture the drug at the Halol facility. It may be recalled that the US drug regulator had earlier observed certain current good manufacturing practices (cGMP) deviations at the unit.

SPARC had received a final approval from the USFDA in March this year for the product and it was evaluating several marketing partners for the product.

However, in a communication to the bourses today, the company said that the US drug regulator has issued a complete response letter to its new drug application for the anti-epileptic drug, indicated for adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.

"SPARC has now received a letter from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval,'' it said.

Under the USFDA website, complete response letters are issued when communicating a decision to a drug company that its new drug application or abbreviated new drug application to market a new or generic drug will not be approved in its present form.

SPARC said Sun Pharma is working with USFDA in resolving the cGMP deviations at the facility and has taken several corrective measures.

In a presentation this June, SPARC had said that the market for the drug in the US is at 720 million units and is growing at 5 year compounded annual growth rate (CAGR) of 9 per cent. It had forecast that opportunity exists to market Elepsia XR at significant premium to generics. Commercialisation of the drug in the US market was slated in the second half of this fiscal.

Under new regulations, USFDA's Center for Drug Evaluation and Research (CDER) no longer issues "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER issues a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application.

Glenmark to focus on dermatology medication

Mumbai-based Glenmark Pharmaceuticals Ltd will focus on developing medications for ailments relating to cardiology, dermatology and respiratory conditions.

Speaking on the sidelines of the launch of Diabetes treatment drugs using Teneligliptin-based drugs Ziten and Zita Plus, Sujesh Vasudevan, President and Head – India Business, Glenmark Pharmaceuticals, said dermatology is one of the fastest-growing areas as more people are giving importance to beauty and wellness.

“Though the products are sold based on prescription, people are increasingly opting for dermatology and cosmetology clinics because of the trust factor in the doctors rather than over-the-counter beauty products,” Vasudevan said.

The company will also be launching Teneligliptin and Metformin combination product, which is currently under clinical trials at 30 centres.

Glenmark expecting USFDA nod for 4-6 products this fiscal

Glenmark Pharmaceuticals is expecting approvals for four to six new products during the fiscal from the US Food and Drug Administration (USFDA), a senior official said on Monday. 

We are expecting approvals for 4-6 products from the USFDA during this year," Glenmark Pharmaceuticals President and Head-India Business Sujesh Vasudevan told reporters here on the sidelines of launch of Teneligliptin in Telangana. The company had already got approvals for eight products this year, he added. Teneligliptin, a new third generation oral anti-diabetic agent, is used for the management of Type 2 Diabetes Mellitus. Glenmark has launched this molecule under two brands, Ziten and Zita Plus, at Rs 19.90 per tablet. "The launch of these two products will lower the daily cost of treatment for a diabetes patient on Gliptin therapy by approximately 55 percent," Vasudevan said. Glenmark's diabetes segment is valued at around Rs 100 crore, Vasudevan said, adding it is growing at 20 percent per annum. Reacting to a query, he said, "The capex for this year is Rs 600 crore and majority of this will go for the plant in the US."

Glenmark to launch 10-12 new products in India, eyes 18-20 per cent growth

Mumbai headquartered drug firm Glenmark Pharmaceuticals proposes to launch 10-12 new products in the domestic market during the current financial year (2015-16) and hopes to report a growth of 18-20 per cent, said a top official. 

The Rs 6,600 crore firm in revenues last fiscal, earns over a fourth of revenues from the domestic market, mostly focusing on dermatology and diabetes drugs. The company may also look at acquiring brands or companies aimed at strengthening its market share in t .. 

We are going to launch 10-12 new products in India this year. We have already launched 4 products so far. New product launches would help us maintaining the high growth rate at around 18-20 per cent when the industry is growing at about 12 per cent", said Vasudevan while addressing journalists in Hyderabad on Monday on the eve of launching new oral drug Teneligliptin for type-2 diabetes. 

Glenmark, which currently earns around Rs 100 crore from the diabetes segment with a year on year growth of around 20 per cent, is planning to grow significantly with the help of new product launches going forward. 

"Our new combination drug of tenegliptin and metformin is under clinical trials now. We will launch this product once we get the approvals from the authorities", said Sujesh. 

He said the domestic diabetes drugs market is currently estimated at around Rs 6,600 crore and gliptins account for around Rs 1,200 crore. 

Neutral rating on Cipla, Sun Pharma no game changer: Sarabjit Kour Nangra, Angel Broking, Pharma

In an interview with ET Now, Sarabjit Kour Nangra, VP - Research, Angel Broking, Pharma, shares his views on markets. Excerpts: 

ET Now: What is that you have made of the USFDA approval for Lupin for a drug of the Goa plant and does Lupin become a buy right now? 

Sarabjit Kour Nangra: This is definitely positive because we expect that Goa facility is not a big issue. It is just a few observations which have come in and we believe that  that it is positive because it indicates that probably they will overcome it. We have a neutral rating on the stock. We do not think the current valuations justify a buy rating on the stock. 

ET Now: What about Sun Pharma, do you think these two product approvals that they have got, how big an opportunity are those for Sun Pharma? 

Sarabjit Kour Nangra: It is a good opportunity in the sense it is a specialised generic, nonetheless it is a generic because the product is already generic and there are various copies available to the product, but since it is a variation, it is in a capsule form, most of the oral products are equivalent available  in the branded and generic market are in the form of tablets, so this is a capsule with a higher dosage. 

So, for the Sun PharmaBSE 0.28 % given its competitive edge and given the efficacy of the product, it can easily do 80 to 50 million on a conservative basis to begin with and then scale up the product. As of now, it is not a game changer but it can be as the product scales up over a period of years. So, it is good news and the ANDA approval that they have got is also of decent size  o it will add to the company but since the company is so big that such small approvals do not add significantly. 

source: http://economictimes.indiatimes.com/articleshow/48556552.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst.. 

Sun Pharma, Lupin Surge on New Drug Approval

Sun Pharma and Lupin shares surged on Thursday in an otherwise weak market after both the companies got approval for new drugs from the US Food and Drug Administration (USFDA). The new drug approvals for Sun Pharma and Lupin can offer millions of dollars in revenues to these companies.

Lupin has received approval from the US FDA for Fenofibrate tablets in dosages of 160 mg and 54 mg, which is used to reduce cholesterol level in human body and reduce risk of cardiovascular disease.

Analysts say, total annual revenues expected from the drug is about $154 million and the competition in this drug is limited to only three generic players.

Lupin has got approval to manufacture the drug from its Goa plant, which had got Form 483 (observation letter) from the USFDA in July. However, this approval indicates that observations at Goa plant are not disruptive and pushed its shares as much as 8.1 per cent higher.

Similarly, Sun Pharma shares advanced over 4 per cent after the pharma major received approval for generic drug Xenazine, which is used for treatment of acne.

Analysts say the market for Xenazine is around $319 million annually and Sun Pharma can expect sales of $6-7 million per month from this drug. Sun Pharma expects to launch this product in last quarter of 2015.

Lupin shares closed 5.30 per cent higher at Rs 1,890.55 and Sun Pharma shares ended 0.91 per cent higher at Rs 935.65 apiece, compared to 1.44 per cent loss in the broader Nifty.